Back to resultsSequential Treatment of Psoriasis With Integrated Traditional Chinese and Western Medicine
Primary Purpose
Plaque Psoriasis
Status
Unknown status
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Jueyin granules
moving cupping therapy
NB-UVB therapy
Jueyin placebo granules
moving cupping placebo therapy
NB-UVB placebo phototherapy
Sponsored by
About this trial
This is an interventional treatment trial for Plaque Psoriasis focused on measuring Plaque Psoriasis, Jueyin granule, Moving cupping, NB-UVB, combination of Chinese traditional and Western medicine
Eligibility Criteria
Inclusion Criteria:
- Plaque psoriasis, the course of disease is not limited.
- Skin lesions involving ≤ 15% BSA (the lesions are mainly located in the trunk and / or limbs, palm / sole, face / scalp, vulva area is not included).
- 18 to 65 years old, male or female patient.
- Informed consent must be obtained.
Exclusion Criteria:
- other active skin diseases which may affect the condition assessment are present.
- Patients who received systematic treatment of research drugs, biological agents and immunosuppressive agents within 2 months.
- Patients who received treatment with topical glucocorticoids, phototherapy, etc. within 2 weeks.
- Those with severe, uncontrollable local or systemic acute or chronic infections.
- patients with severe systemic diseases; or clinical test indicators in one of the following cases: alanine transferase or glutamate transferase increased by >1.5 times the upper limit of normal; serum creatinine increased by >1.5 times the upper limit of normal Any of the main blood routine indicators (white blood cell count, red blood cell count, hemoglobin amount, platelet count) below the lower limit of normal; or other laboratory abnormalities judged by the investigator are not suitable for participation in this trial.
- Patients with a history of malignant tumors and patients with primary or secondary immunodeficiency and hypersensitivity.
- Patients underwent major surgery within 8 weeks or will require such surgery during the study period.
- Patients who are pregnant or in lactation.
- Those have a history of alcohol abuse, drug abuse or drug abuse.
- Patients with a history of serious mental illness or family history.
- Patients with a family history of cancer.
- Other reasons that the investigator considered inappropriate to participate in the study.
Sites / Locations
- The Second People's Hospital Affiliated to Fujian University of TCM
- Wuhan No.1 Hospital
- Jiangsu Province Hospital of Traditional Chinese Medicine
- Chinese Medicine Hospital Affiliated to Southwest Medical University
- Shanghai Dermatology Hospital
- Shanghai Yueyang Integrated Medicine Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm Type
Experimental
Experimental
Experimental
Experimental
Experimental
Arm Label
Chinese medicine internal treatment group
Chinese medicine external treatment group
Chinese medicine treatment group
Western medicine treatment group
Integrated Chinese and Western Medicine Treatment Group
Arm Description
Participants in Chinese medicine internal treatment group will receive Jueyin granule two times daily after meals and moving cupping placebo therapy three times per week for 8 weeks.
Participants in Chinese medicine internal treatment group will receive Jueyin placebo granule two times daily after meals and moving cupping therapy three times per week for 8 weeks.
Participants in Chinese medicine treatment group will receive Jueyin granule two times daily after meals, moving cupping therapy and NB-UVB placebo therapy three times per week for 8 weeks.
Participants in Western medicine treatment group will receive Jueyin placebo granules two times daily after meals, moving cupping placebo therapy and NB-UVB therapy three times per week for 8 weeks.
Participants in Chinese and Western Medicine Treatment Group will receive Jueyin granules two times daily after meals, moving cupping therapy and NB-UVB therapy three times per week for 8 weeks.
Outcomes
Primary Outcome Measures
Psoriasis area and severity index
Psoriasis Area and Severity Index involves grading psoriatic plaques based on erythema (E), infiltration (I), desquamation (D). Severity is graded from 0-4 for each criteria (0 - none, 1 - slight, 2 - moderate, 3 - severe, and 4 - very severe). The body is divided into 4 regions, head, upper extremities, trunk, and lower extremities, and for each region, the surface area involvement is graded on a 0-6 scale (0 - 0% involvement, 1 - <10%, 2 - 10-<30%, 3 - 30-<50%, 4 - 50-<70%, 5 - 70-<90%, 6 - 90-100%).The highest potential PASI score is 72, with higher PASI scores indicating worse psoriasis.
Secondary Outcome Measures
Body surface area (BSA)
The percentage of BSA involved in psoriasis is estimated by fingerprinting, where the entire palm of the patient represents approximately 1% of the total BSA. The number of handprints on psoriasis skin in a body part is used to determine the extent to which the body part is affected by psoriasis (%)
Physician Global Assessment (PGA)
Physician Global Assessment (PGA) is scored on a 5-point scale, reflecting a global consideration of the erythema (E), infiltration (I), desquamation (D) across all psoriatic lesions. It is calculated as follows: PGA score = (E + I + D) / 3, then the score needs to be rounded to the nearest whole number [PGA scale: Clear (0) - Very Severe (5)].
Dermatology Life quality index(DLQI)
The Dermatology Life Quality Index (DLQI) is a participant-reported questionnaire used to measure the health-related quality of life (QOL) of adults suffering from a skin disease. Scores range from 0-30, a higher score indicating a greater impact on a participant's quality of life.
Patient-reported quality of life (PRQoL)
PRQoL is used to assess the impact of psoriasis on individual social life. Scores range from 0-25, a higher score indicating a greater impact on a participant's social life.
Visual Analogue Score (VAS)
Visual Analog Scale (VAS) is used to measure lesion pruritus from 0 to 100 mm at eash visit (with 0 being no pruritis and 100 being maximum pruritis).
TCM symptom score
The TCM symptom score is used to assess changes in blood syndrome related symptoms during treatment.
Full Information
NCT ID
NCT03941431
First Posted
May 1, 2019
Last Updated
May 6, 2019
Sponsor
Shanghai Yueyang Integrated Medicine Hospital
Collaborators
Shanghai Dermatology Hospital, Chinese Medicine Hospital Affiliated to Southwest Medical University, Wuhan No.1 Hospital, The Second People's Hospital Affiliated to Fujian University of TCM, Jiangsu Province Hospital of Traditional Chinese Medicine
1. Study Identification
Unique Protocol Identification Number
NCT03941431
Brief Title
Sequential Treatment of Psoriasis With Integrated Traditional Chinese and Western Medicine
Official Title
Optimally Sequential Treatment of Integrated Chinese and Western Medicine for Psoriasis: a Multicenter Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
May 2019
Overall Recruitment Status
Unknown status
Study Start Date
June 1, 2019 (Anticipated)
Primary Completion Date
December 31, 2021 (Anticipated)
Study Completion Date
December 31, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Shanghai Yueyang Integrated Medicine Hospital
Collaborators
Shanghai Dermatology Hospital, Chinese Medicine Hospital Affiliated to Southwest Medical University, Wuhan No.1 Hospital, The Second People's Hospital Affiliated to Fujian University of TCM, Jiangsu Province Hospital of Traditional Chinese Medicine
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of this study was to explore intervention time of Chinese medicine and specification of a sequential treatment plan for severe psoriasis with Chinese and Western medicine.
Detailed Description
Psoriasis is a chronic, relapsing, inflammatory disease that seriously affects the quality of life of patients. Both Chinese medicine and Western medicine have many methods for treating psoriasis, each with its own advantages and disadvantages, but the pursuit of green and effective treatment programs is still the focus of the work of specialists and researchers. How to combine the existing safe and effective Chinese and Western medicine methods organically, and to achieve the purpose of improving efficacy under the premise of ensuring safety, is the motivation for carrying out this research.
The treatments involved in this study include cupping, phototherapy, and Chinese medicine. All three methods have sufficient literature to confirm their effectiveness in treating plaque psoriasis. The research team hopes to obtain a best combination of three treatments for plaque psoriasis by using a multicenter, randomized, single-blind, controlled trial.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Plaque Psoriasis
Keywords
Plaque Psoriasis, Jueyin granule, Moving cupping, NB-UVB, combination of Chinese traditional and Western medicine
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
378 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Chinese medicine internal treatment group
Arm Type
Experimental
Arm Description
Participants in Chinese medicine internal treatment group will receive Jueyin granule two times daily after meals and moving cupping placebo therapy three times per week for 8 weeks.
Arm Title
Chinese medicine external treatment group
Arm Type
Experimental
Arm Description
Participants in Chinese medicine internal treatment group will receive Jueyin placebo granule two times daily after meals and moving cupping therapy three times per week for 8 weeks.
Arm Title
Chinese medicine treatment group
Arm Type
Experimental
Arm Description
Participants in Chinese medicine treatment group will receive Jueyin granule two times daily after meals, moving cupping therapy and NB-UVB placebo therapy three times per week for 8 weeks.
Arm Title
Western medicine treatment group
Arm Type
Experimental
Arm Description
Participants in Western medicine treatment group will receive Jueyin placebo granules two times daily after meals, moving cupping placebo therapy and NB-UVB therapy three times per week for 8 weeks.
Arm Title
Integrated Chinese and Western Medicine Treatment Group
Arm Type
Experimental
Arm Description
Participants in Chinese and Western Medicine Treatment Group will receive Jueyin granules two times daily after meals, moving cupping therapy and NB-UVB therapy three times per week for 8 weeks.
Intervention Type
Drug
Intervention Name(s)
Jueyin granules
Other Intervention Name(s)
Chinese Herbal Medicine
Intervention Description
Jueyin granules p.o. once a day for 8 weeks.
Intervention Type
Device
Intervention Name(s)
moving cupping therapy
Intervention Description
Moving cupping therapy three times per week for 8 weeks.
Intervention Type
Device
Intervention Name(s)
NB-UVB therapy
Intervention Description
NB-UVB phototherapy three times per week for 8 weeks.
Intervention Type
Drug
Intervention Name(s)
Jueyin placebo granules
Other Intervention Name(s)
Chinese Herbal Medicine
Intervention Description
Jueyin placebo granules p.o. once a day for 8 weeks.
Intervention Type
Device
Intervention Name(s)
moving cupping placebo therapy
Intervention Description
Moving cupping placebo therapy three times per week for 8 weeks.
Intervention Type
Device
Intervention Name(s)
NB-UVB placebo phototherapy
Intervention Description
NB-UVB placebo phototherapy three times per week for 8 weeks.
Primary Outcome Measure Information:
Title
Psoriasis area and severity index
Description
Psoriasis Area and Severity Index involves grading psoriatic plaques based on erythema (E), infiltration (I), desquamation (D). Severity is graded from 0-4 for each criteria (0 - none, 1 - slight, 2 - moderate, 3 - severe, and 4 - very severe). The body is divided into 4 regions, head, upper extremities, trunk, and lower extremities, and for each region, the surface area involvement is graded on a 0-6 scale (0 - 0% involvement, 1 - <10%, 2 - 10-<30%, 3 - 30-<50%, 4 - 50-<70%, 5 - 70-<90%, 6 - 90-100%).The highest potential PASI score is 72, with higher PASI scores indicating worse psoriasis.
Time Frame
Up to 56 days after treatment.
Secondary Outcome Measure Information:
Title
Body surface area (BSA)
Description
The percentage of BSA involved in psoriasis is estimated by fingerprinting, where the entire palm of the patient represents approximately 1% of the total BSA. The number of handprints on psoriasis skin in a body part is used to determine the extent to which the body part is affected by psoriasis (%)
Time Frame
Up to 56 days after treatment.
Title
Physician Global Assessment (PGA)
Description
Physician Global Assessment (PGA) is scored on a 5-point scale, reflecting a global consideration of the erythema (E), infiltration (I), desquamation (D) across all psoriatic lesions. It is calculated as follows: PGA score = (E + I + D) / 3, then the score needs to be rounded to the nearest whole number [PGA scale: Clear (0) - Very Severe (5)].
Time Frame
Up to 56 days after treatment.
Title
Dermatology Life quality index(DLQI)
Description
The Dermatology Life Quality Index (DLQI) is a participant-reported questionnaire used to measure the health-related quality of life (QOL) of adults suffering from a skin disease. Scores range from 0-30, a higher score indicating a greater impact on a participant's quality of life.
Time Frame
Up to 56 days after treatment.
Title
Patient-reported quality of life (PRQoL)
Description
PRQoL is used to assess the impact of psoriasis on individual social life. Scores range from 0-25, a higher score indicating a greater impact on a participant's social life.
Time Frame
Up to 56 days after treatment.
Title
Visual Analogue Score (VAS)
Description
Visual Analog Scale (VAS) is used to measure lesion pruritus from 0 to 100 mm at eash visit (with 0 being no pruritis and 100 being maximum pruritis).
Time Frame
Up to 56 days after treatment.
Title
TCM symptom score
Description
The TCM symptom score is used to assess changes in blood syndrome related symptoms during treatment.
Time Frame
Up to 56 days after treatment.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Plaque psoriasis, the course of disease is not limited.
Skin lesions involving ≤ 15% BSA (the lesions are mainly located in the trunk and / or limbs, palm / sole, face / scalp, vulva area is not included).
18 to 65 years old, male or female patient.
Informed consent must be obtained.
Exclusion Criteria:
other active skin diseases which may affect the condition assessment are present.
Patients who received systematic treatment of research drugs, biological agents and immunosuppressive agents within 2 months.
Patients who received treatment with topical glucocorticoids, phototherapy, etc. within 2 weeks.
Those with severe, uncontrollable local or systemic acute or chronic infections.
patients with severe systemic diseases; or clinical test indicators in one of the following cases: alanine transferase or glutamate transferase increased by >1.5 times the upper limit of normal; serum creatinine increased by >1.5 times the upper limit of normal Any of the main blood routine indicators (white blood cell count, red blood cell count, hemoglobin amount, platelet count) below the lower limit of normal; or other laboratory abnormalities judged by the investigator are not suitable for participation in this trial.
Patients with a history of malignant tumors and patients with primary or secondary immunodeficiency and hypersensitivity.
Patients underwent major surgery within 8 weeks or will require such surgery during the study period.
Patients who are pregnant or in lactation.
Those have a history of alcohol abuse, drug abuse or drug abuse.
Patients with a history of serious mental illness or family history.
Patients with a family history of cancer.
Other reasons that the investigator considered inappropriate to participate in the study.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Bin Li
Phone
0086-021-55981301
Email
18930568129@163.com
First Name & Middle Initial & Last Name or Official Title & Degree
Xiaoying Sun
Phone
0086-021-65161782-3137
Email
dr_xiaoying@126.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jia Zhou
Organizational Affiliation
Department of dermatology, Shanghai Yueyang Integrated Medicine Hospital, Shanghai
Official's Role
Study Chair
Facility Information:
Facility Name
The Second People's Hospital Affiliated to Fujian University of TCM
City
Fuzhou
State/Province
Fujian
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ning Huang
Facility Name
Wuhan No.1 Hospital
City
Wuhan
State/Province
Hubei
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xiaoyong Zhou
Facility Name
Jiangsu Province Hospital of Traditional Chinese Medicine
City
Nanjing
State/Province
Jiangsu
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yuegang Wei
Facility Name
Chinese Medicine Hospital Affiliated to Southwest Medical University
City
Luzhou
State/Province
Sichuan
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wenxin Yang
Facility Name
Shanghai Dermatology Hospital
City
Shanghai
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yangfeng Ding
Facility Name
Shanghai Yueyang Integrated Medicine Hospital
City
Shanghai
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bin Li
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
32228720
Citation
Sun X, Zhou X, Wei Y, Yang W, Huang N, Ding Y, Hu R, Guo S, Yang C, Weng H, Zhang Y, Chen X, Ding X, Liu L, Yin Q, Wang R, Li X, Li B. Our Choice: study protocol for a randomized controlled trial for optimal implementation of psoriasis treatment by the integration of Chinese and western medicine. Trials. 2020 Mar 30;21(1):299. doi: 10.1186/s13063-020-4209-3.
Results Reference
derived
Learn more about this trial
Sequential Treatment of Psoriasis With Integrated Traditional Chinese and Western Medicine
We'll reach out to this number within 24 hrs